Carvedi-Denk 25 tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

carvedilol

Disponibil de la:

Artesan Pharma GmbH & Co. KG

Codul ATC:

C07AG02

INN (nume internaţional):

carvedilol

Dozare:

25mg

Forma farmaceutică:

tablets

Unități în pachet:

(30/3x10/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-08-08

Prospect

1
Version: 6299/002
CARVEDI-DENK 25
Tablet – oral use
Beta blocker
Active substance: carvedilol
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Carvedi-Denk 25 is and what it is used for
2.
What you need to know before you take Carvedi-Denk 25
3.
How to take Carvedi-Denk 25
4.
Possible side effects
5.
How to store Carvedi-Denk 25
6.
Contents of the pack and other information
1.
WHAT CARVEDI-DENK 25 IS AND WHAT IT IS USED FOR
Carvedi-Denk 25 belongs to the beta blocker group of medicinal
products (medicines for treating high
blood pressure or increased heart rate).
Carvedi-Denk 25 is used for heart/circulatory diseases.
Carvedi-Denk 25 is used for

essential high blood pressure (not organically caused)

chronic stable angina pectoris

all degrees of stable chronic heart failure (cardiac insufficiency),
of ischaemic or nonischaemic
origin (dependent or not on circulation disorders). Use is accompanied
by treatment with diuretics
and ACE inhibitors and, if need be, digitalis (medicines acting on the
heart and vascular system)
Carvedi-Denk 25 may be used for essential hypertension alone or in
combination with other blood
pressure-lowering medicines, especially thiazide diuretics.
Patients with heart failure should have been clinically stable on
standard heart failure therapy (e.g.
diuretics, digitalis, ACE inhibitors) for approximately 4 weeks before
starting treatment with Carvedi-
Denk 25.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDI-DENK

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carvedi-Denk 6.25 mg tablets
Carvedi-Denk 25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: carvedilol
_Carvedi-Denk 6.25 mg tablets: _
Each tablet contains 6.25 mg carvedilol.
_Carvedi-Denk 25 mg tablets: _
Each tablet contains 25 mg carvedilol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, whitish, half-scored tablets.
_ _
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is a non-selective beta and alpha1 receptor
antagonist.
Carvedi-Denk is used in adults.
_Carvedi-Denk 6.25 mg tablets: _
-
Chronic heart failure:
In the absence of contraindications, Carvedi-Denk 6.25 mg is indicated
in all patients with
stable, symptomatic, chronic heart failure of ischaemic or
non-ischaemic origin of any intensity,
combined with standard therapy (such as ACE inhibitors and diuretics
with or without digitalis).
_Carvedi-Denk 25 mg tablets: _
-
Essential hypertension
-
Chronic stable angina pectoris
-
Chronic heart failure:
In the absence of contraindications, Carvedi-Denk 25 mg is indicated
in all patients with stable,
symptomatic, chronic heart failure of ischaemic or non-ischaemic
origin of any intensity,
combined with standard therapy (such as ACE inhibitors and diuretics
with or without digitalis).
2
_Note (on use in chronic heart failure): _
Treatment with carvedilol may be commenced only if the patient's
condition has been stabilised on
conventional, basic heart failure therapy, i.e. the dosage of this
existing, standard therapy must have
remained stable for at least four weeks prior to starting treatment
with carvedilol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Essential hypertension _
Treatment should begin with 12.5 mg carvedilol once daily on the first
two days. Treatment can then
be continued with 25 mg carvedilol once daily. As a rule, 25 mg
carvedilol once daily is sufficient.
If the effect is inad